1. Technical Field of the Invention
The present invention relates to an organ anastomosing apparatus and method for forming a bypass by strongly pinching and pressing walls of the adjacent organs of a subject such as patient by adsorbing a pair of magnets to each other so as to cause apoptosis to locally occur and forming a through hole (a passage) for making communication between the organs and anastomosis region around the through hole.
2. Prior Art
In general, the anastomosis of organs such as gut of a body of a subject (which may be described as subject""s body hereinlater) is frequently performed to form a bypass (a through hole) between two cavity guts, for example, in order to flow the content of the gut or bile of bile duct again when constriction of the gut or bile duct progresses by its tumor, ulcer, inflammation, or trauma and the like.
An example of a conventional organ anastomosing apparatus used for such type of the anastomosis is described in Japanese Patent Laid-open Publication No. HEI 9-10218. In this example, a pair of magnets capable of being automatically self-centered are disposed on both sides of two organ walls to be anastomosed. By adsorption of a pair of the large and small magnets, the organ walls are strongly pinched from both sides and are compressed (pressed to be pinched) to cause apoptosis to locally occur, thereby forming the anastomosis with the through hole (fistula) and the peripheral rim (edge) of a small magnet is formed at a sharp cut rim (edge) for promoting the anastomosis.
However, in such conventional organ anastomosing apparatus, the peripheral rim of a small magnet is formed at a sharp cut rim. Thus, there is a fear that the other many organs mare damaged by the cut rim until this small magnet is inserted into a predetermined organ, is inducted into a predetermined site (region), and is disposed at the site.
In addition, after the anastomosis with the through hole has been formed by the adsorption of a pair of magnets, there is no means for holding the through hole formation. Thus, after the anastomosis, for example, it is required to take complicated steps, such that a drainage tube is inserted into the body independent of the organ anastomosing apparatus and inducted to the through hole to be inserted into the through hole, and that the inserted state must be maintained about three months until the anastomosis has been completed.
Further, an N-pole face and an S-pole face on the adsorption surfaces of a pair of magnets each have only one face. Thus, if the adsorption surfaces are disposed in opposite to each other with high precision via an organ wall of the subject, the same poles resist against each other and cannot be adsorbed by each other so that it is required for these magnets to have high disposition precision, and a pair of magnets are not always adsorbed easily.
The present invention was conceived to overcome or solve the defects or problems encountered in the prior art mentioned above and to provide an organ anastomosing apparatus and method capable of safely disposing a pair of magnets at predetermined sites or regions each in one of organs without almost damaging the other organ and forming anastomosis and capable of simply and reliably achieving through hole formation after the anastomosis.
It is another object of the present invention to provide an organ anastomosing apparatus and method capable of simply and reliably performing alignment between the adsorption surfaces of a pair of magnets at predetermined regions in the organs of a subject to be anastomosed.
These and other objects can be achieved according to the present invention by providing, in one aspect, an organ anastomosing apparatus comprising:
a pair of magnets being disposed to predetermined sites of organs of a subject to be anastomosed to each other so as to be opposed to each other through wall portions of the respective organs, the magnets being mutually adsorbed to each other so as to form an anastomosis site having a through hole for making communication between the organ walls;
a flexible guide wire detachably mounted to at least one of the paired magnets; and
a guide tube inserted into a body of the subject with the guide wire being inserted therein, the guide tube coming into contact with a guide wire mount surface of the one of magnets so as to support the one magnet when the guide wire is removed from the one magnet, the guide tube being inserted into the through hole of the anastomosis site to maintain formation of the through hole.
In preferred embodiments of this aspect, the apparatus further comprises a cylindrical sheath inserted into the body of the subject from an outside thereof so as to insert the one magnet to which the guide wire is mounted to guide the one magnet in a vicinity of the predetermined sites of organs.
The one magnet has an adsorption surface larger than that of the other one magnet. The paired magnets may be formed in substantially a same size. A surface of the magnet is coated with at least one of an acid resistant membrane and a thrombus resistant membrane. The magnet may be formed of a rare earth element.
The other one magnet is taken into the subject""s body and then guided from an outside thereof by means of an induction magnet to a predetermined site of the organ of the subject. The induction magnet has an N-pole and an S-pole opposite to each other and an axial intermediate portion to which a stem is provided so as to extend in a direction perpendicular to the axial intermediate portion.
The other one magnet is removably pinched by pinching means of an endoscope to be disposed at the predetermined site of the organ of the subject""s body. The pinching means of the endoscope is made of a non-magnetic material. The other one magnet is provided with a flexible non-magnetic holding member to be pinched by the pinching means of the endoscope.
The organ may be one of digestive system, blood vessel, ureter, bladder, skin and bone.
According to the present invention, when a pair of magnets disposed in opposite to each other via each organ wall of the subject""s body are adsorbed to each other, the organ wall is pinched from both sides by a pair of the magnets and is compressed (pressed to be pinched). Then, the apoptosis occurs and the through hole making communication between the organ walls is formed. At the same time, the peripheral rim of the through hole adheres, the anastomosis is formed and a bypass is thereby formed. Then, a guide tube and a guide wire are removed from one magnet. Further, a tip end of the guide tube is inserted into the through hole of the anastomosis site and the inserted state is maintained until the anastomosis has been completed. In this manner, the formation of the through hole at the anastomosis site is maintained. On the other hand, a pair of magnets removed, with being adsorbed to each other, are discharged to the outside of the body together with the dejection.
Therefore, according to the present invention, unlike the prior art, since the peripheral rim of the magnet is not formed at a sharp cut rim. There can be effectively prevented such a fear that the other many organs are damaged by the cut rim until the magnet is inserted into a predetermined organ, is inducted into a predetermined site, and is disposed at the site.
In addition, after the anastomosis with the through hole has been formed on the organ walls by the adsorption of a pair of magnets to thereby form the through hole, the guide tube already inserted into the subject""s body in the vicinity of the anastomosis site together with one magnet is inserted into the through hole of the anastomosis site immediately, and the inserted state is maintained until the anastomosis has been completed. In this manner, the formation of the through hole can be easily maintained. Therefore, unlike the prior art, after the anastomosis, there can be eliminated the complicated steps, such that a drainage tube is inserted into the body independent of the organ anastomosing apparatus and is inducted to the through hole to be inserted into the through hole and that the inserted state must be maintained about three months until anastomosis has been completed.
Further, for example, there are provided a plurality of the adsorption surfaces of the other magnet taken by the subject""s body, and thus, a pair of magnets are easily adsorbed to each other.
One magnet can be guided in the vicinity of a predetermined organ""s site into the subject""s body from the outside thereof by merely inserting the magnet into the sheath and the easiness and precision of the guiding can be improved.
According to the present invention, one magnet has an adsorption surface greater in size than the other magnet. Thus, the adsorption of one magnet to the other magnet at a predetermined site inside of the body can be easily and reliably performed and the operation time can be reduced. Therefore, the fatigue of the subject""s body can be reduced.
In addition, the through hole of the anastomosis site is formed in substantially the same size as that of the adsorption surface of a smaller magnet. This makes it possible to prevent a larger magnet from moving to the organ side of the smaller magnet through the through hole.
According to the present invention, in the case of anastomosis in intestines between large and small intestines, magnets having substantially the same size and shape are used. After the anastomosis has been completed, the magnets are inducted so as to be moved to the large intestine while the magnets being adsorbed to each other, for example, and are discharged to the outside of the body together with dejection.
According to the present invention, the surface of the magnet is coated with an acid resistant membrane. This makes it possible to prevent degeneration or degradation due to oxidization with the acidic fluid inside of the body. In addition, the surface of the magnet is coated with a thrombus resistant membrane. This makes it possible to prevent generation of thrombus due to the magnets in blood.
According to the present invention, since the magnet is made of a rare earth element, a magnetic force can be strengthened. For this reason, even in the case where a thick organ wall is targeted for forming the anastomosis, the adsorption between the magnets can be easily and reliably performed and the operation time can be reduced.
In addition, a pair of magnets having strong magnetic forces are adsorbed to each other, and thus, there can be improved the apoptosis of the organ wall to be strongly pressed to be pinched by the magnets, the reliability of the formations of the through hole and the anastomosis of the periphery of the through hole.
According to the present invention, after the other magnet has been taken into the subject""s body, the magnet can be guided from the outside of the body to the predetermined organ site by means of the induction magnet. Thus, a work for positioning the other magnet can be simplified and the positioning precision can be improved.
According to the present invention, the N-pole and S-pole are provided at both ends in the axial direction of the magnet main body. Thus, a stem of the magnet is turned around its central axis, whereby the magnetic pole of the magnet main body is properly adsorbed or resisted towards the magnet in the body and the magnet can be inducted to a predetermined site in the body.
According to the present invention, the other magnet is removably pinched by pinching means such as pinching forceps of an endoscope and is disposed at a predetermined site of an organ. Thus, the other magnet can be disposed at the predetermined organ site while observing the carrying state of the magnet in the body by the endoscope. For this reason, the positioning precision of the other magnet can be improved.
The pinching means such as pinching forceps of the endoscope is made of a non-magnetic material. This makes it possible to prevent a magnet from being hardly removed from the pinching means due to the adsorption of the magnet to the pinching means of the endoscope. Furthermore, the other magnet comprises a non-magnetic flexible soft pinching member to be pinched by the pinching means of an endoscope. Thus, the non-magnetic holding member of the other magnet can be easily and reliably pinched by the pinching means of the endoscope. Moreover, since the holding member of the other magnet is soft, the organs in the subject""s body can be prevented from being damaged.
According to the present invention, the organ anastomosing apparatus according to any one of the first aspect to the eleventh aspect can be used to form the anastomosis of any organ including digestive system, blood vessel, ureter, bladder, skin, and bone.
In another aspect of the present invention, there is provided an organ anastomosing method comprising the steps of:
preparing a pair of magnets to at least one of which a flexible guide wire is detachably mounted, guide tube to be disposed to come into contact with a guide wire mount surface of the one magnet and a cylindrical sheath to guide the guide wire;
disposing one of a pair of magnets at a predetermined site of one of organ walls of a subject to be anastomosed to each other;
inserting the cylindrical sheath from an outside of a subject into a body of the subject;
inserting the other magnet for detachably mounting the flexible guide wire into the sheath and inserting the magnet into the other one of organ walls so as to dispose the magnet at a predetermined site, the organ being adsorbed by the one magnet to pinch a portion of the organ wall by a pair of the magnets;
forming a through hole for making communication between the organ walls by pinching the organ walls and forming an anastomosis around the through hole;
removing the guide wire from the other one magnet by pulling the guide wire towards the outside of a body of the subject at a time when the guide tube is inserted into the sheath so as to support a tip end of the guide tube in contact with a guide wire mount surface of the other one magnet;
leaving the guide tube for a predetermined period of time while inserting the guide tube into the through hole of the anastomosis site; and
pulling out the guide tube from the anastomosis site and the subject""s body after an elapse of a predetermined period of time.
In a preferred embodiment of this aspect, the one magnet is inducted from the outside of the body of the subject and guided to the predetermined site of the organ. The one magnet is removably pinched by pinching means of an endoscope and disposed at the predetermined site of the organ. One of the paired magnets has an adsorption surface larger in size than that of the other one magnet.
According to the present invention, after an anastomosis site at which the anastomosis with the through hole is formed on the organ wall due to the adsorption of a pair of magnets is formed, when a guide tube is inserted into the subject""s body while a guide wire is inserted therein, and the guide wire is pulled towards the outside of the body while the wire is supported in contact with the guide wire mount surface of one magnet, the guide wire is removed from one magnet. Then, when the guide tube is inserted into the through hole of the anastomosis site, a pair of magnets adsorbed to each other are pushed out from the anastomosis site. Then, the guide tube is inserted into the through hole of the anastomosis site and is left in the subject""s body until the anastomosis has been completed and stopped. In this manner, the formation of the through hole of the anastomosis site can be easily maintained. Therefore, as in the prior art, there can be eliminated the complicated steps, such that a drainage tube is inserted into the body independent of the organ anastomosing apparatus and is inducted to the through hole to be inserted into this through hole, and the inserted state must be maintained about three months until anastomosis has been completed and stopped.
According to the present invention, one magnet is inducted from the outside of the body by means of the induction magnet and is guided to a predetermined site of an organ. Thus, there is no need to take an endoscope by the subject""s body and one magnet can be easily guided to the predetermined site of the subject""s body.
According to the present invention, one magnet is removably pinched by pinching means such as pinching forceps of the endoscope and is disposed to a predetermined site of an organ. Thus, the magnet can be disposed at the predetermined site of the organ while observing the carrying state of the one magnet in the body by the endoscope. Therefore, the positioning precision of one magnet can be improved.
According to the present invention, one magnet has an adsorption surface greater than the other magnet. Thus, the adsorption to the other magnet at a predetermined site in the body can be easily and reliably performed, and the work time can be reduced. For this reason, the fatigue of the subject""s body can be reduced.
In a further aspect, there is provided an organ anastomosing apparatus, which is characterized in that a pair of magnets are disposed in opposite to each other at a predetermined site of a subject""s organs to be anastomosed each other via respective organ walls, the pair of magnets being adsorbed to each other so as to form an anastomosis site having a through hole making communication between the organ walls and that a large diameter end larger than those of the respective ends and through hole is provided at each end of an opposite side of both the adsorption surfaces of a pair of the magnets.
In this aspect, each magnet has a grip provided on an outer end surface of the large diameter end. The large diameter end of each magnet is made of a row material fusible in the subject""s body after an elapse of a predetermined period of time.
At least one of a pair of magnets is mounted with a spacer made of a non-magnetic material at the other end thereof.
The organ anastomosing apparatus may further comprise a drainage tube to be inserted into the subject""s body, the drainage tube guiding movement of one of a pair of magnets along an outer surface thereof and a sign indicative of the moving direction of the magnet is marked with a radiation transmission-free material.
A substance promoting anastomosis of membrane growth factors in blood vessels or the like is adhered to the magnets or the spacer mentioned above.
According to the present invention, when a pair of magnets disposed in opposite to each other via the organ wall of the subject""s body are adsorbed to each other, the organ wall is pinched by a pair of the magnets from both sides thereof and strongly compressed (pressed to be pinched). Then, the apoptosis occurs, the through hole is formed and the peripheral rim of the through hole adheres, whereby the anastomosis is formed and a bypass is formed. At this time, although a pair of the magnets adsorbed to each other are still inserted into the though hole (bypass), the large diameter end of each of the magnets is greater than a diameter of the through hole. Thus, the end is fitted to the anastomosis site around the through hole and pulling-out is inhibited. Therefore, a pair of magnets adsorbed to each other are left in the state in which the magnets are inserted into the through hole during a desired period of time (for example, about three months), whereby recurrent occlusion due to the progressing of the anastomotic adhesion of the through hole can be prevented.
After the recurrent occlusion has been prevented, one of a pair of magnets adsorbed to each other is pinched by a pinching forceps of the endoscope, for example, and a force for forcibly pulling out the magnet from the through hole is applied thereto, whereby the anastomosis site around the through hole is elastically deformed and the magnet can be pulled out from the through hole. In this manner, the formation of the through hole of the anastomosis site can be maintained.
According to the present invention, a grip is provided on the outer surface of the large diameter end of each magnet. Thus, this grip is pinched by the pinching forceps of the endoscope, for example, whereby the magnet can be moved to a desired site of the desired organ wall in the subject""s body.
According to the present invention, after the through hole (bypass) has been formed between the desired organ walls, even if each magnet is not removed from the subject""s body, when a predetermined period of time is elapsed, the large diameter end of each magnet fitted to the peripheral rim of the through hole is gradually fused, and thus, the fitting is released. For this reason, a pair of magnets are moved to one organ through the through hole of the anastomosis site and are discharged to the outside of the body together with the dejection or the like. Therefore, a work for removing a pair of magnets to the outside of the subject""s body after the bypass formation can be eliminated, and the safety can be improved.
According to the present invention, the axial length (thickness) of the spacer made of a non-magnetic material, which is provided at one end of at least one of a pair of magnets, is properly selected, whereby the magnetic adsorption force of each magnet itself can be properly selected without controlling the adsorption force. Thus, the magnetic adsorption force of the magnet, i.e., organ wall compression force can be properly selected according to a variety of circumferences such as organs to be anastomosed or wall thickness.
According to the present invention, one of a pair of magnets is moved along the outer surface of a drainage tube inserted into the subject""s body, whereby the movement of the magnet can be guided to a desired organ or site by means of a drainage tube.
Moreover, when the magnet is moved while observing the the moving state through radiation transmission, a sign such as arrow marked on the outer surface of the drainage tube by the radiation transmission free material is visually checked, whereby the movement direction is checked. Thus, an erroneous directional movement of the magnet can be prevented, and the efficiency of magnet movement can be improved.
According to the present invention, after the through hole (bypass) has been punched on the desired organ wall by means of a pair of magnets, the anastomosis is promoted in contact with the anastomosis promoter such as membrane growth factors in blood vessels in which the opening peripheral rim of the through hole adheres to the magnets or the spacer.